FDA-Device2012-09-19Class II

CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is used in skin prep

Custom Medical Specialties, Inc.
Hazard

The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.

Sold states
Nationwide Distribution including GA, MI, NY, and PA.
Affected count
16 cases
Manufactured in
330 East Main Street, N/A, Pine Level, NC, United States
Products
CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is used in skin prep

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2329-2012

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